Summary
Overview
Work History
Education
Skills
Timeline
Generic

SACHINKUMAR PATEL

Summary

Experienced in Pharmaceutical Industry and Retail Pharmacy more than ten years of working, to ensure the highest quality outcomes possible. Adept in providing suggestions and solutions to improve and enhance productivity. Bringing forth a seasoned history of helping companies to achieve success and improve efficiency.

Overview

10
10
years of professional experience

Work History

Regulatory Affairs Specialist

Sunrise Pharmaceutical Inc.
11.2023 - Current
  • Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
  • Conducted thorough audits to identify areas of improvement and implement corrective actions for regulatory compliance.
  • Maintain and validate Standard Operating Procedures (SOPs) to ensure compliance with FDA regulations and Good Manufacturing Practice (GMP) guidelines.
  • Manage issuance and control of batch records, analytical records, and material-related documents.
  • Conduct sampling and inspection of raw materials, in-process, and finished drug products for commercial, validation, and ANDA batches.
  • Review packaging and labeling batch records for accuracy and compliance.
  • Assist in creating and implementing processes for generic drugs.
  • Maintain raw material inventory and equipment usage logbooks.
  • Assess manufacturing operations for GMP compliance and resolve any issues.
  • Conduct internal audits and author validation protocols.
  • Perform analytical testing of solid dosage form finished products and raw materials.
  • Calibrate analytical instruments and troubleshoot as needed.
  • Review and approve production batch records, SOPs, and validation protocols.
  • Collaborate cross-functionally to meet work targets and communicate effectively with colleagues.
  • Maintain documentation, including QC documents and product development files.

Regulatory Affairs Specialist

ST Jesus Pharmacy Corp
10.2023 - 11.2023
  • Maintaining and Validation of Standard Operating Procedures (SOPs)
  • Issue and control of bath records, analytical records, and material related documents
  • Maintaining GMP training documents
  • Issue controlled copies of master documents to the user documents
  • Perform internal audits for compliance of regulations and company policies, author and execute process, packaging and cleaning validation protocols and prepare reports, validate SOPs, and control analytical records
  • Perform calibration of PH meter, dissolution apparatus and UV spectrophotometer in accordance with Company SOPs, execute cleaning validation and maintain working documents such as cleaning logbook, equipment logbook, different area logbook and change control documentation, etc
  • Maintain and troubleshooting analytical instruments
  • Writing and updating stability reports
  • Reviewing analytical reports and analyst notebooks, maintaining data, and assisting in quality control processes
  • Work closely with the other departments to meet work targets on time
  • Validate Analytical Procedures of formulations
  • Effectively communicate to other researchers at the company to provide consultation, written reports, and verbal presentations describing methods, analytical data, and interpretation of result

Sr-Pharmacist at Retail

Shree Krishna Medical and Provision Store
06.2018 - 01.2023
  • Providing advice about health issues, symptoms and medications in response to customer enquiries
  • Processing prescriptions and dispensing medication
  • Advised patients on medication side effects and contraindications and explained proper administration
  • Managed drug and supply inventories.
  • Ordering and selling medicines and other stock.
  • Meeting medical representatives.
  • Assisted other pharmacy staff with drug inventory, purchasing and receiving.
  • Managing budgets, keeping statistical and financial records.
  • Preparing publicity materials and displays, marketing services.

Production Executive

Intas Pharmaceuticals Ltd
09.2013 - 05.2018
  • Coordinates in planning and organizing the manufacturing process of the company
  • Implements Operational manuals, production plans, and programs
  • Ensures conformance of manufacturing processes with organizational objectives and policies with the coordination of the Manager
  • Checks the availability of adequate raw and packing materials, utilities, filters, and machine-size parts
  • Fulfills the monthly and weekly production plans according to the schedule with the coordination of the Manager
  • Review of the executed documents and review the documents for compliance including log books, Batch Manufacturing & Packing records, Validation protocols and reports, etc
  • Monitors drug manufacturing activities in compliance with the requirements of cGMP
  • Ensures that all standard yields are maintained by production lines
  • Execute quality improvement testing and activities
  • Develop quality assurance standards and company processes
  • Makes sure the on-the-job training of staff
  • Create quality measurements to track improvement in products
  • Ensures the general cleanliness and hygienic conditions of the manufacturing areas
  • Assists in pilot scale trials of products under development
  • Ensures that there is discipline and good working culture among the staff.

Education

Master of Pharmacy -

Gujarat Technological University
Ahmedabad, Gujarat
07.2013

Bachelor of Pharmacy -

Hemchandracharya North Gujarat University
Patan, Gujarat
06.2011

Skills

  • Problem-solving skills
  • Excellent observational skills and attention to detail
  • Planning, organization and project management skills
  • Communication and interpersonal skills
  • Strong IT and numeracy skills
  • Good time management
  • Ability to work well in multidisciplinary teams

Timeline

Regulatory Affairs Specialist

Sunrise Pharmaceutical Inc.
11.2023 - Current

Regulatory Affairs Specialist

ST Jesus Pharmacy Corp
10.2023 - 11.2023

Sr-Pharmacist at Retail

Shree Krishna Medical and Provision Store
06.2018 - 01.2023

Production Executive

Intas Pharmaceuticals Ltd
09.2013 - 05.2018

Master of Pharmacy -

Gujarat Technological University

Bachelor of Pharmacy -

Hemchandracharya North Gujarat University
SACHINKUMAR PATEL